Tx Quality Manager - 23andMeView Company Profile
- Job Title
- Tx Quality Manager
- Job Location
- South San Francisco, California
- Job Description
Who We Are
23andMe, the leading consumer genetics and research company, has accumulated a wealth of genotypic and phenotypic information from participants committed to improving human health through advances in genomics. Our Therapeutics team in South San Francisco leverages this data to discover and develop new treatments that can offer significant benefits for patients with serious, unmet medical needs.
This dedicated research and drug development group identifies novel targets using 23andMe's genetic database and performs preclinical research to advance programs towards clinical development. We currently have programs across several therapeutic areas, including but not limited to oncology, respiratory, and cardiovascular diseases. More information about our Therapeutics team is available at https://therapeutics.23andme.com/.
The Quality Manager at 23andMe Therapeutics, Quality, is responsible for providing oversight and support for 23andMe Therapeutics' GxP activities and external partners and will report directly to the Head of Therapeutics. Quality handles quality issues such as batch release, external supplier management, routine production issues, deviations, change controls, regulatory compliance issues, quality agreements, as well as managing and tracking key performance indicators for internal and external customers.
Your role will be to work with cross-functional teams at 23andMe Therapeutics to continue to develop, implement, and monitor 23andMe Therapeutics' quality management system.
What You’ll Do
- Represent Quality in GxP related compliance/in team as it relates to manufacturing, testing and analytical controls and conducting clinical trials.
- Participate in the implementation of GMP activities as required by internal procedures and application of regulatory requirements.
- Lead and support activities related to external quality such as, but not limited to, development of process and analytical methods, tech transfers, deviations/investigations, quality agreements, lot dispositions, supplier and contract manufacturing selection and qualifications.
- Provide quality oversight of key CMC and IND enabling documents. Review and verify process data to assure compliance with data integrity.
- Oversee the Quality System development and management. Drive process and product quality through effective quality systems and supplier oversight/surveillance
- Represent Quality on project teams, Health Authority Inspections, suppliers and CDMO operational meetings, and QA to QA meetings.
- Balance efforts and risk based approach to QA oversight of the manufacture and disposition of pre-clinical, early clinical and late phase product materials, DS, DP and Finished Goods at CDMOs in partnership with Technical Operations, CMC, regulatory Affairs and other functions.
What You’ll Bring
- Bachelors or advanced degree in Biology, Chemistry, Chemical Engineering or related field.
- Minimum 10 years of industry, Quality Assurance experience preferred.
- Strong understanding of Device, and biologics manufacturing with direct experience in supplier quality management
- Ability to make timely and sound quality decisions when faced with complex supply, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
- A successful track record working with suppliers and CDMOs.
- Knowledge of Quality Management Systems and Quality Risk Management; experience in implementing and managing quality systems in the pharmaceutical industry.
- Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.
- Understanding of QP requirements and processes a plus.
- Excellent verbal and written communication skills.
- Collaborative, analytical and interpretative skills.
- Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others. Prior management experience is required.
- Previous experience in successfully leading assigned activities within cross-functional teams.
- Some travel required.
23andMe, headquartered in Sunnyvale, CA, is a leading consumer genetics and research company. Founded in 2006, the company’s mission is to help people access, understand, and benefit from the human genome. 23andMe has pioneered direct access to genetic information as the only company with multiple FDA authorizations for genetic health risk reports. The company has created the world’s largest crowdsourced platform for genetic research, with 80 percent of its customers electing to participate. The platform also powers the 23andMe Therapeutics group, currently pursuing drug discovery programs rooted in human genetics across a spectrum of disease areas, including oncology, respiratory, and cardiovascular diseases, in addition to other therapeutic areas. More information is available at www.23andMe.com.
At 23andMe, we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at email@example.com. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.
Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.
23andMe takes a market-based approach to pay, and amounts will vary depending on your geographic location. The salary range reflected here is for a candidate based in the San Francisco Bay Area. The successful candidate’s starting pay will be determined based on job-related skills, experience, qualifications, work location, and market conditions. These ranges may be modified in the future.San Francisco Bay Area Base Pay Range$136,000—$204,000 USD
23andMe Headquarters Location
Mountain View, CA
23andMe Company Size
Between 500 - 1,000 employees
23andMe Founded Year
23andMe Total Amount Raised
23andMe Funding RoundsView funding details
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